Etiology and Prognosis of sICH Based on Hemorrhage Location

NCT ID: NCT06498778

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

698 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-05-31

Brief Summary

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The investigators retrospectively collected participants with spontaneous cerebral hemorrhage(sICH) from January 2015 to December 2019 for training and internal validation. Clinical and imaging data were collected. Modified Rankin Scale (mRS) scores were determined good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6". The location features of sICH were extracted by symptom mapping. Noncontrast computed tomography images of patients and hematoma masks were registered with standard human brain templates to identify specific affected brain regions. Then a probability map of hemorrhage for different causes and prognosis is generated. PyRadiomics was used to extract the radiomic features, integrate radiomic and clinical features into multiple logistic regression models, and develop and validate optimal etiological and prognostic models. Further tests were performed in an independent cohort. The area under the working characteristic curve (AUC), sensibility, specificity were used to evaluate the reliability of the model.

Detailed Description

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Conditions

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Spontaneous Intracerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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good outcome

Modified Rankin Scale (mRS) scores were determined based on clinical examinations or telephone follow-ups at twelve months post sICH event. Consistent with prior literature, we defined good outcome as "mRS = 0-2".

No interventions assigned to this group

poor outcome

Modified Rankin Scale (mRS) scores were determined based on clinical examinations or telephone follow-ups at twelve months post sICH event. Consistent with prior literature, we defined poor outcome as "mRS = 3-6".

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The confirmation of intracranial hemorrhage was achieved through NCCT.

Exclusion Criteria

* They presented with secondary hemorrhage resulting from head trauma, hemorrhagic transformation of ischemic infarction, brain tumors, or exhibited abnormalities in blood coagulation, liver, kidney function, or were subject to drug-induced cerebral hemorrhage
* Only postoperative CT images were available
* Lost follow-up records
* CT image artifacts
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Guangming Lu

Director of the Medical Imaging Center of the Jinling Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guangming Lu

Role: STUDY_DIRECTOR

Deparetment of Radiology, Jinling Hospital

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.

Reference Type BACKGROUND
PMID: 35579034 (View on PubMed)

Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

Reference Type BACKGROUND
PMID: 27145936 (View on PubMed)

Liu X, Zhang Q, Li J, Xu Q, Zhuo Z, Li J, Zhou X, Lu M, Zhou Q, Pan H, Wu N, Zhou Q, Shi F, Lu G, Liu Y, Zhang Z. Coordinatized lesion location analysis empowering ROI-based radiomics diagnosis on brain gliomas. Eur Radiol. 2023 Dec;33(12):8776-8787. doi: 10.1007/s00330-023-09871-y. Epub 2023 Jun 29.

Reference Type BACKGROUND
PMID: 37382614 (View on PubMed)

Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.

Reference Type BACKGROUND
PMID: 37314250 (View on PubMed)

Boe NJ, Hald SM, Jensen MM, Kristensen LMB, Bojsen JA, Elhakim MT, Clausen A, Moller S, Hallas J, Garcia Rodriguez LA, Selim M, Goldstein LB, Al-Shahi Salman R, Gaist D. Major Cardiovascular Events After Spontaneous Intracerebral Hemorrhage by Hematoma Location. JAMA Netw Open. 2023 Apr 3;6(4):e235882. doi: 10.1001/jamanetworkopen.2023.5882.

Reference Type BACKGROUND
PMID: 37017964 (View on PubMed)

Other Identifiers

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2022DZGZR-074

Identifier Type: -

Identifier Source: org_study_id

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